Nabriva Reports Third Quarter 2016 Financial Results

VIENNA, Austria and KING OF PRUSSIA, Pa., Nov. 16, 2016 (GLOBE NEWSWIRE) -- (NASDAQ:NBRV) - Nabriva Therapeutics AG, a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today reported its financial results for the three and nine months ended September 30, 2016.

 "In the third quarter, we diligently advanced our clinical development program with lefamulin for the treatment of Community Acquired Bacterial Pneumonia (CABP)," said Dr. Colin Broom, Chief Executive Officer of Nabriva. "Based on our current enrollment estimates, we remain on schedule to reach our goal of 60% enrollment for our first global registrational trial, Lefamulin Evaluation Against Pneumonia (LEAP) 1, later this year. Additionally, based on our estimates regarding patient enrollment in our two ongoing Phase 3 clinical trials for the treatment of CABP, we continue to believe our current cash resources will be sufficient to fund our operations through the receipt of top-line clinical data from both of these Phase 3 CABP trials, which is anticipated in the second half of next year."

RECENT AND UPCOMING CORPORATE AND OPERATIONAL HIGHLIGHTS
  • Nabriva presented data at the Infectious Disease (ID) Week 2016 Conference in October 2016, highlighting the differentiation of lefamulin's therapeutic approach and pharmacokinetic-pharmacodynamic rationale for selection of the IV and oral dosing in the current Phase 3 clinical trials of lefamulin.
  • Following Nabriva's Annual General Meeting, Daniel Burgess was appointed as Chairman of the Supervisory Board, and Mark Corrigan, M.D., and Stephen Webster were added as members of its Supervisory Board. 
  • Nabriva anticipates reaching 60% enrollment for its LEAP 1 trial in the fourth quarter of 2016 and then plans to subsequently conduct a confirmatory analysis to determine the trial's final enrollment size.
  • On November 11, 2016, Nabriva publicly announced its plan to raise additional capital through a rights offering.

FINANCIAL HIGHLIGHTS
  • For the three months ended September 30, 2016, Nabriva reported a net loss of $13.9 million or $6.56 per share, compared to a net loss of $8.2 million or $7.27 per share for the three months ended September 30, 2015.
  • Research and development expense increased by $4.3 million from $7.8 million for the three months ended September 30, 2015 to $12.1 million for the three months ended September 30, 2016. The increase was primarily due to higher costs related to our Phase 3 clinical trials of lefamulin.
  • General and administrative expense increased by $1.1 million from $1.8 million for the three months ended September 30, 2015 to $2.9 million for the three months ended September 30, 2016. This increase was primarily due to an increase in costs related to the addition of employees in the United States (including non-cash compensation expense), as well as an increase in professional service fees and other general operating expenses related to operating as a public company.
  • As of September 30, 2016, Nabriva had $73.9 million in cash, cash equivalents and marketable securities and term deposits on the balance sheet compared to $111.4 million as of December 31, 2015.

FINANCIAL REVIEW

Overview

We are a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics. We are developing our lead product candidate, lefamulin, to be the first pleuromutilin antibiotic for systemic administration in humans. We are developing both intravenous, or IV, and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia, or CABP, and intend to develop lefamulin for additional indications other than pneumonia. We initiated two pivotal, international Phase 3 clinical trials of lefamulin for the treatment of moderate to severe CABP. These are the first clinical trials we have conducted with lefamulin for the treatment of CABP. We initiated the first of these trials in September 2015 and the second trial in April 2016. Based on our estimates regarding patient enrollment, we expect to have top-line data available for both trials in the second half of 2017. If the results of these trials are favorable, including achievement of the primary efficacy endpoints of the trials, we expect to submit applications for marketing approval for lefamulin for the treatment of CABP in both the United States and Europe in 2018.

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